amphotericin b

Generic: amphotericin b

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amphotericin b
Generic Name amphotericin b
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTABLE, LIPOSOMAL
Routes
INTRAVENOUS
Active Ingredients

amphotericin b 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-954
Product ID 62756-954_e58470e3-e0fe-4bf4-84d3-dfb8620f1ac0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212514
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

Established (EPC)
lipid-based polyene antifungal [epc] polyene antifungal [epc]
Chemical Structure
polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756954
Hyphenated Format 62756-954

Supplemental Identifiers

RxCUI
967385
UPC
0362756954014
UNII
7XU7A7DROE
NUI
N0000175510 N0000175498 M0017172

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amphotericin b (source: ndc)
Generic Name amphotericin b (source: ndc)
Application Number ANDA212514 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE
  • 10 CARTON in 1 CARTON (62756-954-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

62756-954-01 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE 62756-954-02 10 CARTON in 1 CARTON (62756-954-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

amphotericin b (50 mg/1)

Linked Drug Pages (1)

Amphotericin B ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e58470e3-e0fe-4bf4-84d3-dfb8620f1ac0", "openfda": {"nui": ["N0000175510", "N0000175498", "M0017172"], "upc": ["0362756954014"], "unii": ["7XU7A7DROE"], "rxcui": ["967385"], "spl_set_id": ["02aadef1-390b-4270-b56d-33452eb89dde"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01)  / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE", "package_ndc": "62756-954-01", "marketing_start_date": "20241201"}, {"sample": false, "description": "10 CARTON in 1 CARTON (62756-954-02)  / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE", "package_ndc": "62756-954-02", "marketing_start_date": "20241201"}], "brand_name": "Amphotericin B", "product_id": "62756-954_e58470e3-e0fe-4bf4-84d3-dfb8620f1ac0", "dosage_form": "INJECTABLE, LIPOSOMAL", "pharm_class": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "62756-954", "generic_name": "Amphotericin B", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amphotericin B", "active_ingredients": [{"name": "AMPHOTERICIN B", "strength": "50 mg/1"}], "application_number": "ANDA212514", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}